ENDOPATH DEXTRUS

Basic Information

• Brand Name: ENDOPATH DEXTRUS
• Primary DI: 10705036002055
• Version / Model: HAP02
• Catalog Number: HAP02
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 5
• Public Version Date: 2022-12-26
• Public Version Status: Update
• Public Device Record Key: 7e464917-19d7-4050-851f-965bcb5e4fcc

Device Description

Endopath Dextrus Seal Cap Assembly with Accessories (Marking Pen, Ruler, and Forearm Wrap)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47432	Radial surgical retractor seal cap	A sterile device intended to be used with a radial surgical retractor to provide an adjustable membrane that functions as an iris valve seal and access port. It is secured to the retaining latches of the external ring of the inserted retractor whereby the operator can open/close the port by turning the upper seal ring (the action revolves the thin membrane similar to the iris shutter of a camera). It is used to facilitate surgical access while helping to maintain pneumoperitoneum during colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705036002059	GS1	CASE	18	In Commercial Distribution
Primary	10705036002055	GS1
Package	20705036002052	GS1	BOX	3	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, Dry place
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry